Actively Recruiting
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
Led by John Paul II Hospital, Krakow · Updated on 2021-07-22
50
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and/or valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study. Academic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.
CONDITIONS
Official Title
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for carotid artery stenting combined with cardiac surgery based on Heart Team and NeuroVascular Team recommendation and local practice
- Signed informed consent form
- Agree to routine follow-up visits and tests during long-term follow-up
- Presence of new or recurrent atherosclerotic lesions
- Symptomatic carotid artery stenosis ≥50% by NASCET angiography with history of ipsilateral transient cerebral ischemia, stroke, or amaurosis fugax within past 6 months
- Asymptomatic carotid artery stenosis 70-80% by NASCET angiography
- Coronary angiography-confirmed multivessel disease or left main stem stenosis with unstable angina or non-ST-segment elevation myocardial infarction symptoms
- Severe symptomatic valvular disease confirmed by echocardiography
You will not qualify if you...
- Expected survival less than 1 year (e.g., cancer)
- Renal failure with GFR < 20 ml/min/1.73 m2 calculated by CKD-EPI formula
- Pregnant women (confirmed by pregnancy test)
- Coagulopathies
- History of hypersensitivity to contrast agents unresponsive to treatment
- Total carotid artery occlusion
- Carotid artery stent protruding into the aortic arch
- Anatomic variations preventing stent implantation
- Significant stenosis of common carotid artery proximal to target lesion
- Mobile atherosclerotic plaques in the aortic arch
- Coronary artery anatomy unsuitable for bypass grafting
- Lack of vascular material available for grafting
- Presence of porcelain aorta
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Poland, 31-202
Actively Recruiting
Research Team
P
Piotr Musialek, MD, DPhil
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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